Sapphire NC Plus

Basic Information

• Brand Name: Sapphire NC Plus
• Primary DI: 06934955916618
• Version / Model: 225-083-2U
• Company Name: OrbusNeich Medical (ShenZhen) Co., Ltd.
• Labeler DUNS: 530923226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-19
• Public Version: 5
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: dfeedd38-387f-43db-95db-8dffb950b606

Device Description

Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	870.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47732	Coronary angioplasty balloon catheter, basic	A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06934955916618	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K162209	000

Device Sizes

Type	Value	Unit	Text
Length	8	Millimeter
Outer Diameter	2.5	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry, dark, cool place.